Office of Research on Women’s Health (ORWH)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Library of Medicine (NLM)
Fogarty International Center (FIC)
National Center for Complementary and Alternative Medicine (NCCAM)
Division of Program Coordination, Planning and Strategic Initiatives, (DPCPSI)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Dietary Supplements (ODS)

Funding Opportunity Title

Administrative Supplements for Research on Sex/Gender Differences (Admin Supp)

The NIH announces the availability of administrative supplements to support research highlighting the impact of sex/gender differences (or similarities) in human health, including behavioral, clinical or preclinical studies. Included are studies relevant to the pathophysiology, clinical presentation, prevention, or treatment of disease. The proposed research should address the objectives of the NIH Strategic Plan for Women’s Health and Sex Differences Research (http://orwh.od.nih.gov/research/strategicplan/index.asp).

Key Dates

Posted Date

November 13, 2012

Open Date (Earliest Submission Date)

December 12, 2012

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

January 11, 2013, by 5:00 PM local time of applicant
organization.

AIDS Application Due Date(s)

January 11, 2013, by 5 PM local time of applicant
organization.

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date

June 2013

Expiration Date

January 12, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the Application Guide (SF424
(R&R) Application Guide or PHS 398
Application Guide, as appropriate) except
where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and
Contracts). Conformance to all requirements (both in the
Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

The mission of the NIH is to seek fundamental knowledge
about the nature and behavior of living systems, and to apply that knowledge to
enhance health, lengthen life, and reduce burdens of illness and disability.
The Office of Research on Women’s Health (ORWH) works in partnership with the
NIH institutes, centers, and offices to ensure that women’s health and
sex/gender differences research is part of the scientific framework.

This FY 2013 Administrative Supplement program is designed
to support research that increases understanding of sex and gender differences
in health and disease, as part of the implementation of the strategic plan
entitled Moving Into The Future With New Dimensions and Strategies: A Vision
for 2020 for Women’s Health Research, http://orwh.od.nih.gov/research/strategicplan/index.asp

BACKGROUND

Women and men are characterized by both sex and gender, as
highlighted in the Institute of Medicine (IOM) report, entitled Exploring the
Biological Contributions to Human Health: Does Sex Matter? (2001). In this
context, sex referred to being male or female according to reproductive organs
and biologic functions assigned by chromosomal complement. Factors that
contribute to biological sex differences include chromosomes, reproduction, and
hormones. Gender referred to socially defined and derived expectations and
roles rooted in biology and shaped by the environment and experience. Sex and
gender are important considerations in many areas of research, including basic
biological, psychological, social, and behavioral studies. Consideration of
these variables is critical to the accurate interpretation and validation of
research findings that affect the various aspects of women’s health and
sex/gender differences research and to the development of personalized
approaches to medicine. Sex and gender variables may also determine how health
and disease processes differ among women, or between women and men, and inform
the development and testing of preventive and therapeutic interventions in both
sexes.

The 2010 NIH Strategic Plan for Women’s Health and Sex
Differences Research, Moving into the Future with New Dimensions and Strategies,
includes five research goals to advance women’s health and a number of specific
objectives under each of the five goals to which the reader is referred for
examples of general areas in which sex/gender differences research is
encouraged. These include a broad range of research on sex/gender differences
in basic science, incorporation of sex/gender differences in the design of new
medical and communication technologies, medical devices and therapeutic drugs;
global health research and in the development of approaches to personalized
medicine. The proposed research in the supplement needs to clearly demonstrate
how the funding will address sex/gender differences. However, the specific
examples under the objectives are meant to be illustrative but not restrictive
of the kinds of research that could be conducted to fulfill the goal of the
administrative supplement. Please see the NIH Strategic Plan, http://orwh.od.nih.gov/research/strategicplan/index.asp

SCOPE OF SUPPORT

The funding mechanism being used to support this program,
administrative supplements, can be used to cover cost increases that are
associated with achieving certain new research objectives as long as they are
within the original scope of the project. Any cost increases need to
result from making modifications to the project in order to take advantage of
opportunities that would increase the value of the project consistent with its
originally approved objectives and purposes.

The research proposed under the administrative supplement
program must be within the original scope of the parent grant. Applicants
should propose research that, if successful, would contribute to a greater
understanding of the implications of sex/gender differences (or similarities)
in human health or disease outcomes. Applicants must address how the proposed
research supports the goals and objectives of the NIH Strategic Plan for
Women’s Health and Sex Differences Research by including a statement at the
beginning of the Research Strategy section of the application.

For example, applicants may use the following approaches to
address sex/gender comparisons:

The addition of another group of subjects (human or animal) of
the opposite sex when subjects of only one sex were used in the original study
for comparative analyses of sex/gender. Applicants proposing to use subjects of
only one sex/gender will be considered non-responsive UNLESS the data will
be compared with those from the opposite sex within the administrative
supplement period;

The addition of more subjects (human or animal) of both sexes to
sufficiently power a study that was insufficiently powered to conduct or detect
a sex/gender difference (or similarity) in the original study; or

The analyses of preexisting data where sex-specific data are
included and power is sufficient, but a sex/gender analysis was not performed
as part of the original study.

Applicants proposing
the addition of subjects to Phase III clinical trials will be considered
non-responsive.

IC
Specific Considerations

Applicants are strongly encouraged to discuss their proposed
supplement project with the IC Program Officer of the parent grant prior to
submission of a supplement application in order to ensure that the supplement
content area fits with the scientific priorities of the IC and is within the
scope of the parent grant; and to ensure that the parent grant mechanism is one
the IC will support for a supplement.

NIDDK-specific Programmatic Interests Language: Areas of interest
for NIDDK include studies that address the importance of sex/gender differences
for disorders and disease mechanisms within our scientific mission. Examples
include the influence of sex/gender differences in urologic, kidney,
hematologic disease; diabetes; endocrinology; metabolic and digestive disease;
and nutrition and obesity. Basic, translational, and clinical science studies
of sex/gender influences are appropriate provided they address important
questions relevant to the NIDDK’s research programs. Please refer to the
NIDDK’s website for more complete information on our scientific mission
(http://www2.niddk.nih.gov/).

NHLBI-specific Programmatic Language: Only R01 grants can be
considered for administrative supplements in this funding opportunity.

All other ICs: Please contact the official listed in the
Scientific/Program Contact(s).

Section II. Award Information

Funding Instrument

The funding instrument will be the same as the parent
award.

Application Types Allowed

Non-competing Administrative Supplements

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications. ORWH
and the participating components intend to commit up to $3.5 million for FY
2013 funding.

Award Budget

Application budgets are limited to no more than the amount
of the current parent award, and must reflect actual needs of the proposed
project.

Budget requests may be for no more than $100,000 in total
costs.

The funding mechanism being used to support this program,
administrative supplements, can be used to cover cost increases that are
associated with achieving certain new research objectives, as long as the
research objectives are within the original scope of the project, or the cost
increases are for unanticipated expenses within the original scope of the
project. Any cost increases need to result from making modifications to the
project that would increase or preserve the overall impact of the project
consistent with its originally approved objectives and purposes.

Award Project Period

The project and budget periods must be within the
currently approved project period for the existing parent award. Only active
awards with at least 18 months remaining will be considered. Awards in no-cost
extension periods are not allowed to submit an application in response to
this FOA.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply
to the applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

All organizations administering an eligible parent award may
apply for a supplement under this announcement.

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

This announcement is for supplements to existing projects.
To be eligible, the parent award must be active and the research proposed in
the supplement must be accomplished within the competitive segment. The
proposed supplement must be to provide for an increase in costs due to
unforeseen circumstances. All additional costs must be within the scope of the
peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement
application must be within the original scope of the NIH-supported grant
project. Applications that propose to add human subjects in order to conduct
exploratory analyses, facilitate sex/gender differences analysis /or to analyze
existing data sets that are adequately powered are considered to be within the
scope of the parent grant

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.

Foreign institutions or domestic institutions with foreign
components must have clearance for shipping of biological samples across
international lines prior to the administrative supplement award.

Required Registrations

Applicant organizations must complete the following registrations
as described in the Application Guide to be eligible to apply for or receive an
award. Applicants must have a valid Dun and Bradstreet Universal Numbering
System (DUNS) number in order to begin each of the following registrations.

System for
Award Management (SAM) – must maintain an active entity registration
(formerly CCR registration), to be renewed at least annually. Use the Sam.gov
“Manage Entity” function to manage your entity registrations. See the Grants
Registration User Guide at SAM.gov for additional information.

All Program Directors/Principal Investigators (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal
Investigator)

Individual(s) must hold an active grant or cooperative
agreement, and the research proposed in the supplement must be accomplished
within the competitive segment of the active award. Individuals are invited to
work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement
may be requested by any or all of the PDs/PIs (in accordance with the existing
leadership plan) and submitted by the awardee institution of the parent award. Do
not use this administrative supplement application to add, delete, or change
the PDs/PIs listed on the parent award. Visit the Multiple Program
Director/Principal Investigator Policy in the SF424 (R&R) Application Guide
for more information.

Applicant organizations may submit more than one
application, provided that each is sufficiently distinct from any other
administrative supplement currently under consideration by the awarding NIH Institute
or Center.

Since applications in response to this announcement will
only receive administrative review by the awarding Institute or Center, and
will not receive a peer review, the NIH policy on resubmissions will not apply.
However, applications not accepted by the Institute or Center for review, or
not funded by the Institute or Center, should not be submitted again without
either responding to any written concerns or contacting the awarding Institute
or Center for instructions first.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants are required to prepare applications according to
the current application forms in accordance with the Application Guide.

For electronic submissions, applicants must download the
SF424 (R&R) application package associated with this funding opportunity
using the “Apply for Grant Electronically” button in this announcement, or use
the eRA Commons streamlined submission process.

2. Content and Form of Application Submission

All forms should be completed for the supplemental
activities only and should not reflect funding or activities for the
previously awarded parent award.

It is critical that applicants follow the instructions in the Application Guide
(SF424
(R&R) Application Guide or PHS 398 Application
Guide, as appropriate) except where instructed in this funding opportunity
announcement to do otherwise. Conformance to the requirements in the
Application Guide is required and strictly enforced. Applications that are out
of compliance with these instructions may be delayed or not accepted for
review.

All page limitations described in the Application Guide and
the Table
of Page Limits must be followed, with the following exceptions or
additional requirements:

The Research Strategy section of the administrative supplement
may not exceed 6 pages.

Application Submission

The process for submitting an application varies depending
on whether the activity code of the parent award requires electronic submission
(as of the submission date of the supplement application). Visit the list of Activity
Codes Processed Electronically by eRA to determine if the activity code of
the parent award has transitioned to electronic submission.

If the parent award’s activity code has not transitioned to
electronic submission, then you must use the PHS 398 Application Forms and
follow the PHS 398 Application Guide.

If the parent award’s activity code has transitioned to
electronic submission, then you may either (A) electronically submit using the
SF424 (R&R) Application Forms and Grants.gov/Apply, (B) electronically
submit using the streamlined submission process of eRA Commons, or (C) submit
using the paper-based PHS 398 Application forms and the PHS 398 Application
Guide.

Instructions for Submissions using Grants.gov/Apply
for electronic-based submissions

For grants with activity
codes that have transitioned to electronic submission using the SF424
(R&R) application forms, administrative supplement requests may be
submitted electronically as a Revision application type on the R&R Cover
Component. Prepare applications using the SF424 (R&R) application forms associated with this announcement. Please note that some
components marked optional in the application package are required for
submission of applications for this announcement. Follow all instructions in
the SF424 (R&R) Application Guide to ensure you complete all appropriate
required and optional components.

Special Instructions for Streamlined
Submissions using the eRA Commons for electronic-based submissions

NIH now offers a streamlined system through the eRA
Commons for submitting administrative supplements. Login to the eRA Commons,
identify the parent award, and prepare an administrative supplement request. A User’s
Guide for submitting through this system is available.

Include the Research Strategy and any other required
documentation (described below) as a PDF file using the “Add Other Attachments”
function. Budget information should be entered for the grantee institution in
the fields provided. There is no template or form available for subaward
information; instead, all subaward information should be included as a separate
attachment showing the funds requested (by budget period) using the same
categories provided for the grantee institution. Also include a budget
justification for the subawardee institution in the same file.

Applications must be prepared using the PHS 398
research grant application forms and instructions for preparing a research
grant application. The grantee institution, on behalf of the PD/PI of the parent
award, must submit the request for supplemental funds directly to the awarding
component that supports the parent award. Submit a signed, typewritten original
of the application, including the checklist, and two signed photocopies in one
package to the Agency Contact listed in the Scientific/Program Contact(s)
section for the IC that funded the parent award.

On the face page of the application form, note that
your application is in response to a specific program announcement, and enter the
title and number of this announcement.

PHS 398
Research Plan Component (Research Plan)

All instructions in the Application Guide must be followed
for all Research Plan sections applicable to the proposed supplement
activities. At a minimum, the Research Strategy section should be completed and
must include a summary or abstract of the funded parent award or project. Other
sections should also be included if they are being changed by the proposed
supplement activities. Applicants should include a statement of relevance of
the proposed research to the goals and objectives of the NIH Strategic Plan for
Women’s Health ((http://orwh.od.nih.gov/research/strategicplan/index.asp as
the first sentence of the research strategy.

Project/Performance Site Locations (Project/Performance
Sites)

Include the primary site where the proposed supplement
activities will be performed. If a portion of the proposed supplement
activities will be performed at any other site(s), identify the locations in
the fields provided.

Senior/Key Personnel Form

List the PD/PI as the first person (regardless of their role
on the supplement activities). List any other Senior/Key Personnel who are
being added through this supplement, or for whom additional funds are being
requested through this supplement; include a biographical sketch for each.
Follow all instructions in the Application Guide. The PD/PI must be the same as
the PD/PI on the parent award. For Multiple PD/PI parent awards, the Contact
PD/PI must be the PD/PI listed on the supplement request, and the supplement
cannot change the Multiple PD/PI team.

R&R Detailed Budget Form (for use with electronic
submissions)

All budgets should be submitted using the R&R Detailed
Budget form, regardless of the form used for the parent award, and should only
include funds requested for the additional supplement activities.

Budget for the Entire Proposed Period of Support (for use
with paper-based submissions)

A proposed budget should be submitted using the PHS 398
budget forms, in accordance with the PHS 398 Application Guide, and should only
include funds requested for the additional supplement activities.

If applicable, include documentation that the proposed research
experience was approved by the Institutional Animal Care and Use Committee (IACUC)
or human subjects Institutional Review Board (IRB) at the grantee institution.
Adherence to the NIH policy for including women and minorities in clinical
studies must also be ensured, if additional human subjects’ involvement is
planned for the supplement component.

The filename provided for each “Other Attachment”
will be the name used for the bookmark in the electronic application in eRA
Commons.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies
described in the NIH
Grants Policy Statement, and procedures for foreign institutions
described throughout the Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications as described above.
Applicants must then complete the submission process by tracking the status of
the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application before the deadline in the eRA
Commons to ensure accurate and successful submission.

For electronic application submission, information on the
submission process and a definition of on-time submission are provided in the SF424(R&R)
Application Guide.

For paper-based application submission, information
on the process of receipt and determining if your application is considered
“on-time” is described in detail in the PHS 398 Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:For applications submitted electronically on the SF424
(R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID
in the Credential fieldof the Senior/Key Person Profile Component of
the SF 424(R&R) Application Package. Failure to register in the
Commons and to include a valid PD/PI Commons ID in the credential field will
prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the Application Guide.

Upon receipt, applications will be evaluated for
completeness by the awarding Institute or Center. Applications that are
incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Not Applicable.

Section V. Application Review Information

1.
Criteria

Administrative Supplements do not receive peer review. Instead,
the administrative criteria described below will be considered in the administrative
evaluation process.

This process involves an initial selection by each
participating NIH institute and center (IC), and a subsequent selection of
supplements to be funded from among the highest ranked supplements submitted by
all ICs participating in this announcement. An integration panel, with
ORWH coordination, will make the final selections. The following general
criteria will be used:

Budget and
Period of Support

NIH Staff will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

Overall Impact

NIH staff will consider the ability of the proposed
supplement activities to increase or preserve the parent award’s overall impact
within the original scope of award:

Will the
administrative supplement increase or preserve the likelihood for the project
to exert a sustained, powerful influence on the research field(s) involved?

Is there
an appropriate plan to accomplish the goals within the time frame proposed?

Are the
team members appropriate to accomplish the research proposed in the supplement?

In addition, each of the following criteria will be evaluated
as applicable for the proposed supplement.

Protections for Human Subjects:

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, NIH staff will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46, NIH
staff will evaluate: 1) the justification for the exemption, 2) human subjects
involvement and characteristics, and 3) sources of materials. For additional
information on review of the Human Subjects section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
NIH staff will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

NIH Staff will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

NIH Staff will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

2. Review and Selection
Process

Administrative supplement requests will undergo an
administrative evaluation by NIH staff, but not a full peer review. Applications
submitted for this funding opportunity will be assigned to the awarding
component for the parent award and will be administratively evaluated using the
criteria shown above.

After IC review and ranking of supplement applications, ORWH
will develop a funding plan with consideration of the following factors:

Rankings from the ICs

Availability of funds.

Relevance of the proposed project to ORWH program priorities and
program balance

Relevance of the proposed project to research on sex/gender
differences

3. Anticipated
Announcement and Award Dates

Not Applicable

Section VI. Award
Administration Information

1. Award Notices

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications.
This may be as an NoA for the supplemental activities only; alternatively, it
may be as either a revision to the current year NoA or included as part of a
future year NoA. The NoA signed by the grants management officer is the
authorizing document and will be sent via email to the grantee’s business
official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any supplements to Cooperative Agreements will be subject to
the same Cooperative Agreement terms and conditions as the parent award.

3. Reporting

Reporting requirements will be specified in the terms and
conditions of award as applicable to the supplemental activities. In most non-competing
continuation applications, the progress report and budget for the supplement
must be included with, but clearly delineated from, the progress report and
budget for the parent award. The progress report must include information about
the activities supported by the supplement even if support for future years is
not requested. Continuation of support for the supplement activities in the
remaining years of the competitive segment of the grant will depend upon
satisfactory review by the NIH awarding component of progress for both the parent
award and the supplement project, the research proposed for the next budget
period, and the appropriateness of the proposed budget for the proposed effort.
This information is submitted with the Non-Competing Grant Progress Report, PHS 2590 or RPPR,
and financial statements as required in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.